ICU Trial in Critical Ill COVID-19 Patients

NCT04349982 | Completed

• 1 other identifier: 250320
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of our study is to observe the intensive care course in 30-50 COVID-19 patients with regard to cardiovascular risk factors and biomarkers. The primary objective of this study is to investigate the cardiovascular risk and its impact on cardiovascular complications in COVID-19 patients in intensive care units. This study is designed to investigate correlations and to investigate factors influencing the course of the new viral disease COVID-19 in intensive care. Previous scientific findings are still rare due to the relevance of the disease, therefore this study is also explorative and not exclusively based on a hypothesis. The cardiovascular risk will be assessed upon admission to the intensive care unit and subsequently the course of biomarkers (see below) will be analysed in a cohort study (no, low and high cardiovascular risk).

Conditions

Risk Factor, Cardiovascular; Covid19; Critical Illness; Course Illness

Keywords

Critical Illness; Covid19; Risk Factor, Cardiovascular

Outcome Measures

Primary Outcomes (1)

• ICU CV risk and Biomarker (e.g. Troponin)

  Troponin courses in the intensive care unit are analyzed in consideration of the respective cardiovascular risk.

  through study completion, up to 4 weeks

Secondary Outcomes (1)

• CV risk and Outcome during ICU stay

  through study completion, up to 4 weeks

Study Arms (3)

No cardiovascular risk

If no patients with no cardiovascular risk can be included in the study, we will divide the cohorts into different categories (e.g. low, medium and high cardiovascular risk).

Diagnostic Test: Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)

low cardiovascular risk

Diagnostic Test: Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)

high cardiovascular risk

Diagnostic Test: Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)

Interventions

Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT) DIAGNOSTIC_TEST

Factorial

Also known as: Fluid management (fluid input, fluid output), prone positioning, ventilation, respiration, circulation parameters, extracorporeal organ support procedures, mortality, MACE, entire drug therapy

No cardiovascular risk; high cardiovascular risk; low cardiovascular risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with respiratory insufficiency and current COVID-19 infection with different gender, age and previous diseases.

You may qualify if:

• Admission on an isolation unit - intensive care unit of the LKH Univ. Klinikum Graz
• Detection of a SARS - CoV-2 infection by PCR (tracheal or pharyngeal secretion) or CT examination (with subsequent PCR detection)
• male and female sex
• subordinated declaration of consent if possible if applicable
• respiratory insufficiency with indication for non-invasive or invasive ventilation

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, Styria, Austria

Location

Related Publications (4)

• Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.

  PMID: 32139904 BACKGROUND

• Li B, Yang J, Zhao F, Zhi L, Wang X, Liu L, Bi Z, Zhao Y. Prevalence and impact of cardiovascular metabolic diseases on COVID-19 in China. Clin Res Cardiol. 2020 May;109(5):531-538. doi: 10.1007/s00392-020-01626-9. Epub 2020 Mar 11.

  PMID: 32161990 BACKGROUND

• Lippi G, Lavie CJ, Sanchis-Gomar F. Cardiac troponin I in patients with coronavirus disease 2019 (COVID-19): Evidence from a meta-analysis. Prog Cardiovasc Dis. 2020 May-Jun;63(3):390-391. doi: 10.1016/j.pcad.2020.03.001. Epub 2020 Mar 10. No abstract available.

  PMID: 32169400 BACKGROUND

• Yang J, Zheng Y, Gou X, Pu K, Chen Z, Guo Q, Ji R, Wang H, Wang Y, Zhou Y. Prevalence of comorbidities and its effects in patients infected with SARS-CoV-2: a systematic review and meta-analysis. Int J Infect Dis. 2020 May;94:91-95. doi: 10.1016/j.ijid.2020.03.017. Epub 2020 Mar 12.

  PMID: 32173574 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Lipid profile once at intensive care unit admission (9 ml whole blood).

MeSH Terms

Conditions

COVID-19; Critical Illness; Disease Progression

Interventions

Prone Position; Inhalation; Respiration

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Respiratory Mechanics; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 16, 2020
• Study Start: April 8, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 31, 2022
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

AU (1)